BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EIGEN FLORO-STOR FS-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRABECULAR METAL GLENOSPHERE DISTRACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code HSD·April 18, 2014

    CAPIOX RX OXYGENATOR W/ HARDSHELL RESERVOIR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·October 12, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 14, 2012

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024